RecruitingPhase 1NCT06834126

Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial

DINOMITE (Decreasing Hypoxia With Mitochondrial Inhibition in Locally Advanced Rectal Cancer): Phase 1 Trial of Papaverine in Combination With Radiation


Sponsor

City of Hope Medical Center

Enrollment

36 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and best dose of papaverine (PPV) when given together with radiation therapy (RT) and tests how well it works in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). PPV is an enzyme inhibitor, and it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Giving PPV with RT may be safe, tolerable, and/or effective in treating patients with locally advanced rectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called DINOMITE) tests whether adding papaverine — a drug that relaxes blood vessel walls and may reduce low-oxygen conditions in tumors — to radiation therapy can improve outcomes for people with locally advanced rectal cancer who want to avoid surgery. **You may be eligible if...** - You are 18 or older with good performance status - You have been diagnosed with rectal adenocarcinoma (confirmed by biopsy) that has not spread to other organs - Your tumor is locally advanced (T3-T4 or involves lymph nodes) - Your tumor is microsatellite stable (MSS) — a specific genetic marker - You want to pursue a non-surgical treatment approach after completing standard intensive chemotherapy and radiation - You are willing to undergo MRI scans, tissue biopsies, and blood and stool collection **You may NOT be eligible if...** - Your tumor has spread to distant organs (metastatic) - Your tumor is MSI-high (a different genetic type) - You have serious heart conditions or cannot tolerate the required procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood and tissue sample collection

PROCEDUREComputed Tomography

Undergo CT

DRUGConsolidation Therapy

Receive CC with mFOLFOX6 or CAPOX

PROCEDUREFunctional Magnetic Resonance Imaging

Undergo fMRI

PROCEDUREGastrointestinal Endoscopy

Undergo endoscopy

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGPapaverine

Given IV

RADIATIONRadiation Therapy

Undergo RT

PROCEDURETotal Mesorectal Excision

Undergo ToME


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06834126


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